Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT)

Novartis

Status and phase: Completed; Phase 3

Conditions: Acute Decompensated Heart Failure; Congestive Heart Failure

Treatments: Drug: Placebo; Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894387

2009-010236-18 (EudraCT Number)

CSPP100A2368

Details and patient eligibility

About

This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

Enrollment: 1,639 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.

• Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.

  • LVEF < 40% (measured within the last 6 months).
  • Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.

• Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).

• Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).

Exclusion criteria

• Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
• Concomitant use of ACEI and ARB at randomization.
• Right heart failure due to pulmonary disease.
• Diagnosis of postpartum cardiomyopathy.
• Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
• Patients with a history of heart transplant or who are on a transplant list.
• Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.

Other protocol-defined inclusion/exclusion criteria applied.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,639 participants in 2 patient groups, including a placebo group

Aliskiren

Experimental group

Description:

Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.

Treatment:

Drug: Aliskiren

Placebo

Placebo Comparator group

Description:

Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.

Treatment:

Drug: Placebo